- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07239193
Demineralized Dentin Matrix Versus Mineralized Plasmatic Matrix on Alveolar Ridge Preservation in Molar Extraction Sites
Effect of Demineralized Dentin Matrix Versus Mineralized Plasmatic Matrix on Alveolar Ridge Preservation in Molar Extraction Sites; A Randomized Clinical Trial.
When a tooth is removed, the bone around it (called the alveolar ridge) naturally shrinks. This study compares two bone grafting materials to find out which one better preserves bone after molar extraction:
Demineralized Dentin Matrix (DDM): A material made from the patient's own extracted tooth, treated to remove minerals while keeping bone-forming proteins.
Mineralized Plasmatic Matrix (MPM): A mixture of a standard bone substitute and platelet-rich plasma from the patient's blood.
Study Overview
Status
Conditions
Detailed Description
Alveolar ridge resorption is a predictable biological process following tooth extraction, particularly in molar sites where the bone structure is more complex. Maintaining ridge volume is essential for optimal future implant placement and prosthetic rehabilitation. Various grafting materials and biologic enhancers have been used to minimize post-extraction bone loss; however, cost, availability, and biocompatibility remain significant challenges, especially with xenograft and allograft materials.
This randomized clinical trial investigates and compares two autogenous and biologically enhanced approaches for alveolar ridge preservation following molar extraction. The first method utilizes Demineralized Dentin Matrix (DDM) prepared from the patient's own extracted tooth. DDM provides a naturally derived scaffold rich in collagen and bone morphogenetic proteins (BMPs), offering both osteoconductive and osteoinductive potential. The second method uses a Mineralized Plasmatic Matrix (MPM), a combination of a xenograft bone substitute mixed with Platelet-Rich Plasma (PRP), which represents a widely used regenerative option in oral surgery.
The study is designed as a parallel-group, single-blind, randomized clinical trial conducted at the Oral and Maxillofacial Surgery Department, Faculty of Dentistry, Cairo University. Eligible adult patients requiring extraction of non-restorable multi-rooted molars will be enrolled and allocated equally into two groups. Both groups will undergo atraumatic extraction followed by immediate socket grafting with either DDM+PRF or MPM+PRP.
Standardized postoperative care will be provided to all participants, and healing will be monitored both clinically and radiographically. Cone-beam computed tomography (CBCT) will be used to evaluate alveolar bone width, height, and density immediately after extraction and at 4 months postoperatively. Pain and soft-tissue healing will also be assessed using validated clinical indices.
The study's primary objective is to determine whether Demineralized Dentin Matrix (DDM) provides superior preservation of alveolar ridge dimensions and bone quality compared to Mineralized Plasmatic Matrix (MPM) in molar extraction sites. The hypothesis tested is that there will be no significant difference between both materials regarding bone preservation and regeneration outcomes.
This trial is expected to provide evidence supporting the clinical viability of using recycled autogenous tooth material as a cost-effective and biocompatible alternative to commercially available xenografts, potentially expanding regenerative options for clinicians and improving access to affordable biologic grafting solutions.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Cairo, Egypt, 12613
- Faculty of Dentistry, Cairo University - Department of Oral and Maxillofacial Surgery
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Contact:
- Faculty of Dentistry, Cairo University.
- Phone Number: 23634965
- Email: dentmail@dentistry.cu.edu.eg
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Non-restorable tooth indicated for extraction Multi-rooted teeth Age group of 18 to 55 years Patients free from any systemic disease that may affect bone healing.
Exclusion Criteria:
- Pregnant females Active infection at extraction site Smokers Systemic conditions affecting healing (e.g. diabetes, medications as bisphosphonates...) Poor oral hygiene. Patient with systemic disease that may affect bone healing. o Uncooperative patient.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: Demineralized Dentin Matrix (DDM) + Platelet-Rich Fibrin (PRF)
Participants in this group will receive socket grafting using Demineralized Dentin Matrix (DDM) prepared from their own extracted tooth.
The dentin is cleaned, ground into particles, demineralized using 0.6 N hydrochloric acid, rinsed with saline, and mixed with autologous Platelet-Rich Fibrin (PRF) before being placed into the extraction socket.
The socket is then closed with resorbable sutures for healing.
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Autogenous dentin-derived grafting material is used as a bone substitute for alveolar ridge preservation following molar extraction.
PRF, obtained from the patient's centrifuged blood, is mixed with DDM to enhance graft stability and promote healing.
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Active Comparator: Mineralized Plasmatic Matrix (MPM)
Participants in this group will receive socket grafting using a Mineralized Plasmatic Matrix (MPM) composed of a commercially available xenograft mixed with Platelet-Rich Plasma (PRP).
The mixture forms a cohesive mineralized matrix that is placed into the extraction socket and stabilized with sutures.
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A xenogenic bone substitute is mixed with autologous platelet-rich plasma to form a mineralized plasmatic matrix, which serves as a control graft for ridge preservation after molar extraction.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Change in Alveolar Ridge Width
Time Frame: Baseline (immediately postoperative) and 4 months postoperatively.
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Measurement of horizontal bone width at the extraction site using cone-beam computed tomography (CBCT).
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Baseline (immediately postoperative) and 4 months postoperatively.
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Change in Alveolar Ridge Height
Time Frame: Baseline (immediately postoperative) and 4 months postoperatively.
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Measurement of vertical bone height at the extraction site using CBCT.
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Baseline (immediately postoperative) and 4 months postoperatively.
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Change in Bone Density
Time Frame: Baseline (immediately postoperative) and 4 months postoperatively.
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Evaluation of bone density in the grafted socket area using CBCT grayscale values.
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Baseline (immediately postoperative) and 4 months postoperatively.
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Postoperative Pain
Time Frame: 2 days, 1 week, and 1 month postoperatively.
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Subjective evaluation of pain intensity at the surgical site using the Visual Analogue Scale (VAS).
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2 days, 1 week, and 1 month postoperatively.
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Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Tarek Ibrahim ElGhareeb, Phd, department of oral and maxillofacial surgery, faculty of dentistry, Cairo university
- Study Director: Salah Eldin ElAbbasy, Phd, department of oral and maxillofacial surgery, faculty of dentistry, Cairo university
- Principal Investigator: Ahmed Suliman Ahmed, Bds, department of oral and maxillofacial surgery, faculty of dentistry, Cairo university
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- DDM in socket preservation
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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